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United States Patent |
5,634,932
|
Schmidt
|
June 3, 1997
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Cantilever aneurysm clip system
Abstract
A system for clipping an aneurysm which includes an aneurysm clip and an
applicator that allows improved visual control during application. The
aneurysm clip has a unitary, integral, cantilever spring and a unitary,
integral, rigid ring. The cantilever spring has two arms, open in the
unbiased position, provides a spring force, and defines the clipping force
of the aneurysm clip. The cantilever spring also includes bulges
positioned on the outer surface of the arms and a bend at the ends of the
arms. The rigid ring slips over the arms, is retained by the bulges, and
forces the arms together. The applicator includes a first leg including a
pin adapted to engage the bend of the cantilever spring of the aneurysm
clip and a second leg movable relative to the first leg which includes
structure for engaging the rigid ring of the aneurysm clip. A scissoring
or squeezing motion of the applicator handle moves the arms to slide the
rigid ring on and off the arms of the cantilever spring of the aneurysm
clip.
Inventors:
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Schmidt; Ferenc J. (Bryn Mawr, PA)
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Assignee:
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Industrial & Scientific Designs, Ltd. (Dalkey, IE)
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Appl. No.:
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541485 |
Filed:
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October 10, 1995 |
Current U.S. Class: |
606/157; 606/142 |
Intern'l Class: |
A61B 017/08; A61B 017/04 |
Field of Search: |
606/142,144,139,157,158
|
References Cited
U.S. Patent Documents
535798 | Mar., 1895 | Hawkes.
| |
1352978 | Sep., 1920 | Lantieri et al.
| |
3326217 | Jun., 1967 | Kerr.
| |
3518993 | Jul., 1970 | Blake.
| |
4024868 | May., 1977 | Williams.
| |
4440170 | Apr., 1984 | Golden et al.
| |
4478219 | Oct., 1984 | Rozario et al.
| |
4527562 | Jul., 1985 | Mericle.
| |
4681107 | Jul., 1987 | Kees, Jr.
| |
4943298 | Jul., 1990 | Fujita et al.
| |
4966603 | Oct., 1990 | Focelle et al.
| |
5201746 | Apr., 1993 | Shichman.
| |
5234449 | Aug., 1993 | Bruker et al.
| |
5304188 | Apr., 1994 | Marogil.
| |
5354306 | Oct., 1994 | Garvey, III et al.
| |
5520701 | May., 1996 | Lerch | 606/142.
|
Foreign Patent Documents |
0178469 | Apr., 1986 | EP.
| |
0630615 A1 | Dec., 1994 | EP.
| |
Other References
Mizuho Ikakogyo Co. Catalog, pp. 2-7 (Apr., 1995).
AESCULAP (Aneurysm-Clip System) Brochure, 2 pages (1995).
AESCULAP (Forceps) Brochure, 4 pages (1995).
Handbook of Spring Design, p. 31 (Spring Manufacturers Institute 1981).
AESCULAP.RTM. Catalog, 2 pages (1992).
"Spring Design Data," Section 4, p. 4 (AMETEK, Inc. 1964).
European Search Report dated 19. Sep. 1994 (attached to above listed EP
Publication No. 0 630 615).
Axel Perneczky, M.D. and Georg Fries, M.D., "Use of a new aneurysm clip
with an inverted-spring mechanism to facilitate visual control during clip
application," J. Neurosurg, vol. 82, pp. 898-899 (May, 1995).
|
Primary Examiner: Buiz; Michael
Assistant Examiner: Pham; Tina T. D.
Attorney, Agent or Firm: Ratner & Prestia
Claims
What is claimed is:
1. An apparatus for clipping tissue during surgery on a cerebral aneurysm
comprising:
an aneurysm clip allowing visual control during application, providing a
clipping force, and having:
(a) a unitary, single-piece, integral cantilever spring open in the
unbiased position, providing a spring force, and including (i) a first arm
with a first end, a free end, an outer surface, and a first bulge
positioned on said outer surface, (ii) a second arm with a first end, a
free end, and an outer surface, and (iii) a bend disposed between said
first end of said first arm and said first end of said second arm, and
(b) a unitary, single-piece, integral rigid ring adapted to slip over and
completely surround said first and second arms, retained by said bulge on
said first arm, pressing said first and second arms together into a closed
position against the spring force while preventing scissoring of said
first and second arms; and
an applicator allowing visual control during application of said aneurysm
clip and having:
(a) a first leg including a pin adapted to engage said bend of said
cantilever spring of said aneurysm clip;
(b) a second leg movable relative to said first leg and having means for
engaging said rigid ring of said aneurysm clip and sliding said rigid ring
on and off said first and second arms, said first and second legs
positioned adjacent one side of said aneurysm clip rather than around said
aneurysm clip thereby reducing visual obstruction; and
means attached to said first leg and to said second leg for moving said
second leg relative to said first leg.
2. An apparatus according to claim 1 wherein said first arm has a second
bulge and a third bulge positioned on its outer surface and said second
arm has a first bulge, a second bulge, and a third bulge positioned on its
outer surface, said first bulges of said first and second arms preventing
said rigid ring from sliding off said first and second arms in the
direction of said bend, said second bulges of said first and second arms
preventing said rigid ring from sliding off said first and second arms in
the direction of said free ends of said first and second arms, and said
third bulges of said first and second arms engaging said rigid ring and
helping to maintain said rigid ring in position and to provide additional
closing force by forcing said first and second arms of said cantilever
spring together.
3. An apparatus according to claim 2 wherein said first arm has an angle
disposed between its free end and its second bulge and said second arm has
an angle disposed between its free end and its second bulge, said angles
enhancing the clipping force of said aneurysm clip.
4. An apparatus according to claim 1 wherein said cantilever spring is a
material selected from the group consisting of titanium, titanium alloys,
ceramics, plastics, and composites and said material has a rigidity
providing the clipping force of said aneurysm clip.
5. An apparatus according to claim 1 wherein said rigid ring is oval.
6. An apparatus according to claim 1 wherein the spring force provided by
said cantilever spring is the only spring force of said aneurysm clip.
7. An apparatus according to claim 1 wherein said bend has a coil spring
assuring return of said cantilever spring to its open, unbiased position
upon removal of said rigid ring.
8. An apparatus according to claim 1 wherein the thickness of said
cantilever spring is about 0.5 mm, the width of said bend of said
cantilever spring is about 4.5 mm, and the length of said bend of said
cantilever spring is about 4.0 mm, creating a volumetric visual
obstruction of about 0.5.times.4.5.times.4.0 mm.
9. An apparatus according to claim 8 wherein said rigid ring has a height
of about 2 mm and a maximum outside diameter of about 5 mm.
10. An apparatus according to claim 1 wherein said pin is perpendicular to
said first leg.
11. An apparatus according to claim 1 wherein said engaging and sliding
means includes a pair of spaced projections perpendicular to said second
leg, said projections engaging said rigid ring.
12. An apparatus according to claim 1 wherein said moving means includes a
handle having a first blade and a second blade, said first blade attached
to said first leg and said second blade attached to said second leg.
13. An aneurysm clip allowing visual control during application and
providing a clipping force, said aneurysm clip comprising:
a monolithic cantilever spring, produced without any machining operation
requiring at least one of flow and removal of material, open in the
unbiased position, providing a spring force, and having:
(a) a first arm with a first end, a free end, an outer surface, and a first
bulge positioned intermediate said first end and said free end on said
outer surface,
(b) a second arm with a first end, a free end, and an outer surface, and
(c) a bend disposed between said first end of said first arm and said first
end of said second arm; and
a monolithic rigid ring adapted to slip over and completely surround said
first and second arms, retained by said first bulge on said first arm,
pressing said first and second arms together into a closed position
against the spring force while preventing scissoring of said first and
second arms.
14. An aneurysm clip according to claim 13 wherein said first arm has a
second bulge and a third bulge positioned on its outer surface and said
second arm has a first bulge, a second bulge, and a third bulge positioned
on its outer surface, said first bulges of said first and second arms
preventing said rigid ring from sliding off in the direction of said bend,
said second bulges of said first and second arms preventing said rigid
ring from sliding off said first and second arms in the direction of said
free ends of said first and second arms, and said third bulges of said
first and second arms engaging said rigid ring and helping to maintain
said rigid ring in position and to provide additional closing force.
15. An aneurysm clip according to claim 14 wherein said first arm has an
angle disposed between its free end and its second bulge and said second
arm has an angle disposed between its free end and its second bulge, said
angles enhancing the clipping force of said aneurysm clip.
16. An aneurysm clip according to claim 13 wherein said cantilever spring
is a material selected from the group consisting of titanium, titanium
alloys, ceramics, plastics, and composites and said material has a
rigidity providing the clipping force of said aneurysm clip.
17. An aneurysm clip according to claim 13 wherein said rigid ring is oval.
18. An aneurysm clip according to claim 13 wherein the spring force
provided by said cantilever spring is the only spring force of said
aneurysm clip.
19. An aneurysm clip according to claim 13 wherein said bend has a coil
spring assuring return of said cantilever spring to its open, unbiased
position upon removal of said rigid ring.
20. An aneurysm clip according to claim 13 wherein the thickness of said
cantilever spring is about 0.5 mm.
21. An aneurysm clip according to claim 20 wherein the width of said bend
of said cantilever spring is about 4.5 mm and the length of said bend of
said cantilever spring is about 4.0 mm, creating a volumetric visual
obstruction of about 0.5.times.4.5.times.4.0 mm.
22. An aneurysm clip according to claim 21 wherein said rigid ring has a
height of about 2 mm and a maximum outside diameter of about 5 mm.
23. An applicator allowing visual control during application of an aneurysm
clip having (i) a cantilever spring open in the unbiased position
including a pair of arms with a bend disposed between the arms and (ii) a
ring pressing the first and second arms together into a closed position,
said applicator comprising:
a first leg having a pin adapted to engage the bend of the cantilever
spring of the aneurysm clip;
a second leg movable relative to said first leg and having means for
engaging the ring of the aneurysm clip and sliding the ring on and off the
first and second arms, said first and second legs positioned adjacent one
side of the aneurysm clip rather than around the aneurysm clip thereby
reducing visual obstruction; and
means attached to said first leg and to said second leg for moving said
second leg relative to said first leg.
24. An applicator according to claim 23 wherein said pin is perpendicular
to said first leg.
25. An applicator according to claim 23 wherein said engaging and sliding
means includes a pair of spaced projections perpendicular to said second
leg, said projections engaging the ring.
26. An applicator according to claim 23 wherein said moving means includes
a handle having a first blade and a second blade, said first blade
attached to said first leg and said second blade attached to said second
leg.
27. An applicator according to claim 26 wherein said first blade and said
second blade move said second leg relative to said first leg in response
to one of a scissoring and a squeezing force.
Description
FIELD OF THE INVENTION
This invention relates generally to a cerebral aneurysm clip and, in
particular, to an aneurysm clip system that improves visual control during
clip application. The system includes an aneurysm clip, having a
cantilever spring and a rigid ring, and an applicator.
BACKGROUND OF THE INVENTION
A cerebral aneurysm is an expansion of an artery in the brain into the form
of a lump or balloon. Aneurysms are often located behind other blood
vessels and at various angles. They may be difficult to reach. Moreover,
access to a cerebral aneurysm is through a very small opening.
A cerebral aneurysm clip is a surgical instrument which clips the base part
of a cerebral aneurysm to temporarily or permanently isolate it from the
cerebral artery. For this purpose, the clip must maintain its pressure
with high reliability as long as desired without injury to the wall of the
blood vessel. Such injury might be caused, for example, by a shearing
action of the clip arms, which results from improper alignment; improper
clipping pressure; foreign material trapped in cracks and crevices formed
in the clip design; surface imperfections on the clip material which can
tear tissue; or the use of unsuitable materials to manufacture the clip.
FIG. 1 illustrates a conventional cerebral aneurysm clip 10. Clip 10 has a
pair of blades 12 and 14 which are positioned to face each other. A coil
spring 20, generally called a "torsion" spring, is formed between the base
ends 16 and 18 of blades 12 and 14. Typically, coil spring 20 has
one-and-one-half (as shown in FIG. 1) or two-and-one half coils. The free
ends 22 and 24 of blades 12 and 14 clip the aneurysm. Blades 12 and 14 are
opened and closed using the base end 26 of coil spring 20 as a fulcrum.
The elasticity of coil spring 20 provides clip 10 with its clipping force.
FIG. 2 shows how conventional cerebral aneurysm clip 10 is applied using an
applicator 40. Applicator 40 has a pair of jaws 42 and 44 which envelop
and engage the bases 32 and 34 of blades 12 and 14 of clip 10. (As shown
in FIG. 2, conventional applicator 40 is larger than the clip 10 which it
applies; therefore, the combination of clip 10 and applicator 40 provides
a larger visual obstruction than the clip alone.) When jaws 42 and 44 are
compressed, bases 32 and 34 of clip 10 pivot toward one another about base
end 26 and against the force of coil spring 20. That movement opens free
ends 22 and 24 of blades 12 and 14. The neurosurgeon then positions opened
free ends 22.and 24 of blades 12 and 14 around the vessel to be clipped.
When jaws 42 and 44 are subsequently released, bases 32 and 34 of clip 10
pivot away from one another about base end 26 under the force of coil
spring 20. That movement closes free ends 22 and 24 of blades 12 and 14
and clips the aneurysm in the vessel.
Distinguish an aneurysm clip from a "clamp." Clamps use malleable materials
which close like a staple, lack the flexibility of a spring component, and
cannot be removed. Consequently, clamps do not allow precise tailoring of
the closing forces to (1) prevent dislocation, yet (2) prevent necrosis of
the tissues due to overly high pressure. The clamping force is determined
by how tightly the clamp is closed, not by a pre-calibrated spring force.
In addition, clamps cannot form the complex shapes into which clips must
be manufactured. The clip must be applied, through a very small opening,
often deep inside the brain.
When operating on a deep-seated cerebral aneurysm, the neurosurgeon's
visual control of the clip application is restricted by both the clip and
the clip applicator. That problem has been identified, for example, in the
article by A. Perneczky, "Use of a New Aneurysm Clip with an
Inverted-Spring Mechanism to Facilitate Visual Control During Clip
Application," J. Neurosurg 82: 898-899 (1995). Obstruction dimensions for
an aneurysm clip and applicator are typically 9 mm by 5 mm. The 9 mm
dimension represents the width of the clip coil (about 7 mm) plus the
approximately 1 mm applicator head on either side enveloping the clip coil
(see FIG. 2). These dimensions are large when compared to cerebral
arteries as small as 1 mm in diameter.
One recent development (the Perneczky clip) inverts or reverses the clip
action. The applicator grips the inside of the clip and does not envelop
the clip. To open the clip, the applicator is opened; the applicator is
closed to close the clip. This eliminates the applicator as a source of
obstruction. Because the 1 mm obstruction by the applicator on either side
of the clip is eliminated, the obstruction with this clip is typically
reduced to the order of 7.times.5 mm.
A number of different materials are used to manufacture cerebral aneurysm
clips. Most conventional aneurysm clips are limited, however, to metals
and metal alloys (such as stainless steel and chrome-cobalt alloy steel)
because the clips incorporate coil springs and metals and their alloys
provide the necessary spring force to clip tissue. Unfortunately, most
metals and metal alloys interfere with important diagnostic techniques
such as magnetic resonance imaging (MRI or NMR), MRA, and CT-Scanning due
to image degradation (haloing, starbursts, and "Black-Hole" obscuring)
caused by the magnetic characteristic and high density of the materials.
An exception is titanium, which has a very low magnetic susceptibility and
density; therefore, it does not interfere with MRI, MRA, or CT-scan
procedures.
Furthermore, the significant magnetic susceptibility of most metals and
metal alloys presents the danger that clips made of these materials will
move, rotate, or become hot in the intense electro-magnetic fields
created. Aneurysm clips made of non-metallic materials including plastic,
ceramic, or composites--and the exceptional metal titanium--present
advantages, such as minimal interference with MRI, MRA, and CT-scan
diagnostic procedures. The problem of metallic materials of construction
has been discussed in U.S. Pat. No. 4,943,298 issued to Fujita et al.
The cerebral aneurysm clip of the '298 patent has blades made of synthetic
resins or ceramics. The synthetic material can include, for example,
fluorine or methacrylic resins or thermoplastics such as polyethylene or
polypropylene. Table 1 of the '298 patent summarizes applicable ceramic
materials. The advantage of such materials is disclosed as the ability to
make X-ray and MRI examinations without interference from the materials.
The materials also provide an advantage in that they are chemically stable
and harmless to a living body, as well as being corrosion resistant and
durable.
The first embodiment of the '298 patent is an otherwise standard clip
improved by using plastic or ceramic material of construction. This
embodiment is illustrated in FIGS. 1-5 of that patent. The second
embodiment is illustrated in FIGS. 6-10 of the '298 patent. The second
embodiment is a hinged clip, neither closed nor open unless biased, having
blades 14a, 14b or 25a, 25b which pivot about a single point. The clip has
an elastic spring member which is either compressed (see FIGS. 6 and 10)
or stretched (see FIGS. 7-9) to apply a closing force on the blades. The
spring member can be a sleeve shown as element 27 in FIG. 9.
The '298 patent does not disclose any way to prevent the elastic spring
member from slipping on the clip. Moreover, the clipping force is not
developed, in the clip of the '298 patent, by any cantilever action of the
blades. Rather, the clipping force is developed by elastic springs which
are made of rubber or other elastomers. Finally, the '298 patent does not
disclose any type of applicator. It appears, however, that the applicator
must envelop the clip and impair visibility.
Some conventional clip designs require that holes be drilled, components be
welded or riveted, or recesses be formed. Machining processes are often
required. Such manufacturing procedures introduce microcracks, voids, and
crevices into the clip. Sharp corners of recesses and microcracks yield a
clip undesirable for use as a cerebral implant. Thus, drilling, welding,
riveting, and machining steps should be avoided in the processes of
manufacturing an aneurysm clip; otherwise, the clip produced cannot
satisfy the criteria required for a desirable clip.
The aneurysm clip disclosed by Lerch in European Patent Application No.
94108657.1 is an example of a titanium clip which requires problematic
machining steps during manufacture. The clip is made from two rod halves,
each half having a free end, a bump, a curved area, and a foot. The free
ends of the clip halves form the clip jaws. The two rods are held together
by a crimp (which has an edge or shoulder) on the feet. A ring rests on
the curved area of the halves before the clip is applied. Before
application, the ring jaws are spread apart. A hole is drilled through the
ring and a rod is inserted in the hole so that it protrudes on either side
of the ring. The ring is illustrated in FIG. 3 of the application.
The principle problem with the titanium clip disclosed by Lerch is the
requirement that a crimp be provided. The crimp is objectionable, first,
because it is an additional component that increases the cost of the clip
and must be designed and formed with precision. Titanium and its alloys
are notch sensitive; therefore, they are difficult to deform without
cracking. Cracks are likely to occur when the crimp of the clip is formed.
In addition, the crimp has an edge or shoulder that renders the clip
undesirable for use as a cerebral implant. If a more malleable metal than
titanium is used to form the crimp, the advantages of titanium would be
lost and the risk of other problems (such as galvanic corrosion) arises. A
crimping operation is difficult to implement with other, non-metallic
materials of construction such as plastics and ceramics.
Similarly, the drilling operation on the ring may introduce microcracks,
voids, and crevices into the ring. The protruding rod on either side of
the ring yields undesirable extensions on a clip for use as a cerebral
implant. Finally, like the crimp, the protruding rod of the ring is
objectionable because it is an additional component that increases the
cost of the clip and must be designed and formed with precision.
The applicator used to apply the clip has a pistol-like handle, a tube
moved by the handle, and a fixed locator rod inside the tube (see FIG. 1
of the application). The locator rod has a seat with jaws on its end. With
the tube pulled away from the clip, the jaws of the seat on the locator
rod are positioned over the edges of the crimp on the clip (see FIG. 5 of
the application). The user then slides the tube over the locator rod and
forces the jaws of the seat on the locator rod around the edges of the
crimp so that the locator rod holds the crimp of the clip (see FIG. 6 of
the application). The user continues to slide the tube over the locator
rod until an uptake slot on the end of the tube engages the protruding rod
on either side of the ring. Using a wheel, the tube is rotated so that the
uptake slot "catches" the protruding rod. Finally, the user slides the
tube until the clip is within the tube and the ring is positioned over the
bumps on the clip halves. This action forces the jaws of the clip
together. (See FIG. 7 of the application.)
The applicator disclosed by Lerch surrounds the clip. Therefore, the
applicator is larger than the clip and restricts the view of the
neurosurgeon. During application, the neurosurgeon must accomplish the
additional procedural step of rotating the tube so that the uptake slot of
the applicator tube catches the protruding rod of the clip ring. This
introduces another inconvenient and time-consuming procedural step
(requiring the use of two hands), however, and is undesirable because the
uptake slot may fail to catch the clip ring unless the step is performed
correctly.
To overcome the shortcomings of existing aneurysm clips, a new cantilever
aneurysm clip system is provided that reduces visual obstruction. An
object of the present invention is to provide an improved aneurysm clip
incorporating a cantilever spring force. A further object is a design that
does not require coil springs and that can be easily manufactured from
almost any material, including titanium, ceramic, plastic, or composites.
It is still another object of the present invention to provide an improved
applicator that is positioned next to, rather than around, the aneurysm
clip, to further improve visual control. Another object of the present
invention is to achieve an adequate closing force using less spring
material than is required by conventional coil clips; therefore, the
weight of the clip is reduced.
SUMMARY OF THE INVENTION
To achieve these and other objects, and in view of its purposes, the
present invention provides a system for clipping an aneurysm which
includes a unitary, integral, cantilever spring; a rigid ring; and an
applicator that allows improved visual control during application. The
cantilever spring is open in the unbiased position. The rigidity of the
material provides the spring force and defines the clipping force of the
aneurysm clip. The cantilever spring further includes (i) a first arm with
a first end, a free end, an outer surface, and at least one bulge
positioned on the outer surface; (ii) a second arm with a first end, a
free end, an outer surface, and with or without at least one bulge
positioned on the outer surface; and (iii) a generally "U" or "V"-shaped
bend disposed between the first end of the first arm and the first end of
the second arm.
The aneurysm clip also includes a rigid ring with opposing faces adapted to
slip over and completely surround the first and second arms. The ring is
retained by the bulge or bulges on the first, and possibly on the second,
arm. The ring presses the arms together into a closed position against the
spring force, creating a cantilever spring clip rather than a coil spring
clip, while preventing scissoring of the first and second arms.
The cantilever spring aneurysm clip is applied by the neurosurgeon using an
applicator. The applicator of the present invention is a modified Rongeurs
type and allows improved visual control during application of the
cantilever spring aneurysm clip. The applicator includes a first leg
having a pin adapted to engage the "U" or "V"-shaped bend of the
cantilever spring of the aneurysm clip. A second leg moves relative to the
first leg and includes structure for engaging the ring of the aneurysm
clip to slide the ring on and off the arms of the cantilever spring. The
first and second legs are positioned alongside the aneurysm clip rather
than around it, thereby reducing visual obstruction. The applicator has a
handle including a blade attached to each leg to move the second leg
relative to the first leg.
It is to be understood that both the foregoing general description and the
following detailed description are exemplary, but are not restrictive, of
the invention.
BRIEF DESCRIPTION OF THE DRAWING
The invention is best understood from the following detailed description
when read in connection with the accompanying drawings, in which:
FIG. 1 illustrates a conventional aneurysm clip having a coil spring;
FIG. 2 shows how the conventional aneurysm clip illustrated in FIG. 1 is
applied using a known applicator;
FIG. 3 depicts a first embodiment of the aneurysm clip of the present
invention, including a cantilever spring and a rigid ring, in an open
position;
FIG. 4 shows a second (and preferred) embodiment of the aneurysm clip of
the present invention, also with a cantilever spring and a rigid ring, in
a partially closed position;
FIG. 5 illustrates the aneurysm clip shown in FIG. 4 in a fully closed
position;
FIG. 6A is a front view of the rigid ring of the aneurysm clip according to
the present invention;
FIG. 6B is a side view of the rigid ring shown in FIG. 6A;
FIG. 7 shows an embodiment of the cantilever spring component without any
bulges on the second arm according to the present invention;
FIG. 8 is an embodiment of the aneurysm clip according to the present
invention which includes a coil spring disposed in the bend of the
cantilever spring component;
FIG. 9 is an applicator according to the present invention using a
scissoring motion of the handle;
FIG. 10 is another embodiment of the applicator according to the present
invention using a squeezing motion of the handle;
FIG. 11 shows the applicator engaging the bend and rigid ring of the open
aneurysm clip according to the present invention; and
FIG. 12 shows the applicator engaging the bend and rigid ring of the closed
aneurysm clip according to the present invention.
DETAILED DESCRIPTION OF THE INVENTION
As illustrated in the drawings, the clip of the present invention looks
much like a "U" or "V"-shaped hair pin in its simplest embodiment.
Conventional aneurysm clips are based on various coil springs which are
basically similar to clothes pins. The resilient coil spring develops the
closing force in such conventional clips and the spring arms are so short
and stiff that their effect on the closing force is universally neglected.
In contrast, the clip of the present invention substitutes a cantilever
spring force for the coil spring force of the conventional clips, thereby
permitting use of a wide variety of rigid materials (e.g., titanium,
plastics, ceramics, and reinforced composites) some of which do not lend
themselves to forming into a spring coil. In addition, the "U" or
"V"-shape can be cut out from sheets, molded, or formed using a wide
variety of manufacturing techniques. The use of plastics, ceramics, and
reinforced composites offers recognized advantages in many implant
applications.
The closing force developed by the arms, negligible in conventional clips,
is the sole closing force for the clip of the present invention. The
closing force is determined by the rigidity (resistance to bending) of the
material and can be calculated using beam equations--not torsional spring
equations. Thus, the closing force is developed using a different
principle (bending versus torsion spring) than that found in conventional
devices.
Referring now to the drawing, wherein like reference numerals refer to like
elements throughout, FIG. 3 shows a first embodiment of the aneurysm clip
50 of the present invention disposed along longitudinal axis "a". Aneurysm
clip 50 has two components: a cantilever spring 60 and a rigid ring 100.
As discussed above, drilling, welding, riveting, and other machining steps
should be avoided in the processes of manufacturing aneurysm clip 50.
Accordingly, each component of aneurysm clip 50 of the present
invention-cantilever spring 60 and rigid ring 100--is unitary and
integral. FIGS. 4 and 5 illustrate a second embodiment of aneurysm clip 50
as ring 100 is applied to cantilever spring 60.
Cantilever spring 60 of aneurysm clip 50 has a first arm 70 and a second
arm 90. First arm 70 has a free end 72, a first end 74, and an outer
surface 76. Second arm 90 has a free end 92, a first end 94, and an outer
surface 96. Cantilever spring 60 has a generally "U" or "V"-shaped bend 80
disposed between first end 74 of arm 70 and first end 94 of arm 90.
At least one of the outer surfaces, for example outer surface 76, has a
first bulge 77. In the embodiment shown in FIG. 3, outer surface 76 also
has a second bulge 78. FIG. 7 shows an embodiment of cantilever spring 60
without any bulges on second arm 90. Alternatively, as shown in FIG. 3,
outer surface 96 of second arm 90 also may have a first bulge 97 and a
second bulge 98. The function of bulges 77, 78, 97, and 98 will be
described below.
In a preferred embodiment of the invention, cantilever spring 60 has a
width of approximately 4.5 mm and the length of bend 80 is approximately 4
mm. Because cantilever spring 60 avoids the need for a coil spring,
cantilever spring 60 can be made of 0.5 mm thick, flat-strip material in
titanium. Conventional clips require a 1 mm thickness; a thinner material
would not allow formation of a coil spring having sufficient strength.
Accordingly, the volumetric visual obstruction of aneurysm clip 50 is only
0.5.times.4.5.times.4.0 mm.
The second component of aneurysm clip 50 of the present invention is rigid
ring 100. FIG. 6A is a front view of rigid ring 100; FIG. 6B is a side
view of rigid ring 100. Cantilever spring 60 is set for application by
sliding rigid ring 100 with opening 102 over arms 70 and 90 until adjacent
to bend 80 as shown in FIG. 3. The outer diameter of bend 80 is larger
than the inner diameter of ring 100; consequently, ring 100 cannot slide
off cantilever spring 60 in the direction of bend 80.
Cantilever spring 60 is closed by sliding rigid ring 100 with opening 102
and by positioning rigid ring 100 over arms 70 and 90 to press arms 70 and
90 into a gently closed position. Rigid ring 100 is preferably made rigid
and in an oval shape, as shown in FIG. 6A, to prevent sideways movement
(scissoring) of first arm 70 and second arm 90 when rigid ring 100 is
positioned over and around arms 70 and 90. In the preferred embodiment of
the invention, rigid ring 100 has a height of about 2 mm and a maximum
outside diameter of about 5 mm.
As illustrated in FIG. 3, before application of rigid ring 100 to
cantilever spring 60, aneurysm clip 50 might be considered equivalent to a
conventional coil spring clip--albeit with only a one-half coil turn. When
unbiased and before application of rigid ring 100, cantilever spring 60
assumes an open position as shown in FIG. 3. Once applied, however, rigid
ring 100 essentially pins arms 70 and 90 (immobilizing the coil spring
equivalent) and transforms arms 70 and 90 of cantilever spring 60 into
beams restrained at one end (i.e., into cantilever beams).
FIGS. 4 and 5 illustrate a preferred embodiment of cantilever spring 60 of
aneurysm clip 50. Whereas first arm 70 and second arm 90 of cantilever
spring 60 shown in FIG. 3 are each provided with only a first bulge (77
and 97, respectively) and a second bulge (78 and 98, respectively), first
arm 70 and second arm 90 of preferred cantilever spring 60 shown in FIGS.
4 and 5 each have a third bulge 79 and 99, respectively. First bulges 77
and 97 prevent rigid ring 100 from sliding off arms 70 and 90 in the
direction of bend 80. Second bulges 78 and 98 prevent rigid ring 100 from
sliding off arms 70 and 90 in the direction of free ends 72 and 92.
During application, rigid ring 100 is placed adjacent bend 80 (see FIG. 3)
and forced over first bulges 77 and 97 (see FIG. 4) until it seats between
first bulges 77, 97 and second bulges 78, 98 (see FIG. 5). Typically,
second bulges 78 and 98 are larger than first bulges 77 and 97. Thus,
rigid ring 100 is retained between first bulges 77, 97 and second bulges
78, 98.
FIGS. 4 and 5 illustrate a preferred embodiment of cantilever spring 60 in
which arms 70 and 90 each have a third bulge 79 and 99. Like first bulges
77 and 97, third bulges 79 and 99 are smaller than second bulges 78 and
98. Rigid ring 100 engages third bulges 79 and 99, when fully applied to
cantilever spring 60, and third bulges 79 and 99 provide additional
closing pressure. As noted above, the dimensions of aneurysm clip 50 are
critical. Each of bulges 77, 78, 79, 97, 98, and 99 are about 2 mm long
for a clip with a total length of about 27.5 mm.
The preferred embodiment of cantilever spring 60 illustrated in FIGS. 4 and
5 also incorporates another feature not present in the embodiment of
cantilever spring 60 illustrated in FIG. 3: angles for the arms. First and
second arms 70 and 90 may each be provided with an angle 75 and 95,
respectively, in the proximity of third bulges 79 and 99. Angles 75 and 95
are directed inward so that arms 70 and 90 of cantilever spring 60 assume
a non-parallel position having slightly converging free ends 72 and 92
when cantilever spring 60 is in its open position. Distinguish the
embodiment of cantilever spring 60 shown in FIG. 3 in which free ends 72
and 92 are substantially parallel to (and may diverge away from)
longitudinal axis "a" before application.
Arms 70 and 90 continue to converge during the application process (see
FIG. 4). When fully applied to a vessel, however, arms 70 and 90 will
assume a substantially parallel orientation (see FIG. 5). Angles 75 and 95
enhance the cantilever spring force of aneurysm clip 50 so that the
clipping force of aneurysm clip 50 is equal to or greater than the
clipping force generated by the coil spring of conventional clip 10.
Angles 75 and 95 also reduce the risk of slippage of arms 70 and 90 from
the blood vessel. Most significantly, angles 75 and 95 provide a safe
upper limit to the pressure applied to a vessel by aneurysm clip 50 and
reduce the danger of necrosis of the tissue due to excessive pressure.
When aneurysm clip 50 is fully applied to a vessel, arms 70 and 90 will
touch (or nearly touch) in the vicinity of first bulges 77 and 97 (see
FIG. 5). Accordingly, any effect of bend 80 as a "coil" in contributing to
the clipping force of aneurysm clip 50 is cancelled. The clipping force of
aneurysm clip 50 is defined entirely by the rigidity of the material used
to construct cantilever spring 60.
A preferred embodiment of aneurysm clip 50 was constructed of titanium and
tested. Aneurysm clip 50 attained a closing force of between 150-200
grams. Moreover, aneurysm clip 50 required less metal than an equivalent
coil spring clip 10.
Although neither preferred nor illustrated, a single bulge may be provided
on one arm of cantilever spring 60 to retain rigid ring 100. Rigid ring
100 may have a groove on its inside diameter to ride on the single bulge
without danger of slippage. Alternatively, each of the arms 70 and 90 of
cantilever spring 60 may be provided with a single bulge to retain rigid
ring 100. Thus, various combinations of different numbers of bulges on
each arm of cantilever spring 60 are possible. The preferred embodiment of
cantilever spring 60 is shown in FIGS. 4 and 5, however, with each arm 70
and 90 having three bulges.
In the embodiments of the present invention discussed thus far, the spring
force of cantilever spring 60 is the only spring force of aneurysm clip
50. It is sometimes necessary, however, to remove aneurysm clip 50 for
various reasons. For example, the neurosurgeon may try, or "titrate,"
blood flow with clips of various shapes and closing force. Therefore, it
may be desirable to include an additional force to ensure re-opening of
aneurysm clip 50. The additional force is unnecessary for clips made from
sufficiently resilient materials. It is an added safety feature, however,
for materials which could develop a "set" in the closed position due to
plastic flow.
FIG. 8 shows an embodiment of cantilever spring 60 in which a coil spring
110 with at least one coil is positioned in the trough of bend 80 to
provide additional opening force to arms 70 and 90 when rigid ring 100 is
removed. In contrast to coil spring aneurysm clips, like aneurysm clip 10,
the function of coil spring 110 is not to develop closing force (pressing
arms 70 and 90 together); rather, the function is just the opposite--to
ensure re-opening of arms 70 and 90 once rigid ring 100 is removed. Such
re-opening must be made possible because the clips are removed and
repositioned occasionally from cerebral arteries.
The closing force generated by coil spring 110, if one is provided, is nil
or negligible. In either case, the closing force attributable to coil
spring 110 can be neglected in designing aneurysm clip 50 of the present
invention.
FIG. 9 shows an applicator 120 used to apply aneurysm clip 50 of the
present invention. Applicator 120 is a modified "Rongeurs" type of
applicator with a first leg 140 and a second leg 160. First leg 140 has a
pin 142 disposed perpendicular to and near the end of first leg 140. Pin
142 engages bend 80 of cantilever spring 60 of aneurysm clip 50. Pin 142
may include a rounded head 144 with a diameter slightly larger than the
diameter of the body 146 of pin 142 to prevent pin 142 from slipping out
of bend 80 unless a twisting motion is applied. Second leg 160 includes
structure for engaging rigid ring 100 of aneurysm clip 50. In one
exemplary embodiment, such structure consists of two perpendicular
projections 162 and 164 with a space 166 located between projections 162
and 164.
First leg 140 and second leg 160 are mounted so that they are movable
relative, and slide parallel, to one another. Applicator 120 includes a
handle 170 which has a first blade 180 mounted on first leg 140 at the end
of first leg 140 opposite pin 142. Handle 170 also has a second blade 190
mounted on second leg 160 at the end of second leg 160 opposite
projections 162 and 164. Handle 170 moves legs 140 and 160 relative to one
another either by a scissoring motion, as shown by arrow "A" in FIG. 9, or
by a squeezing motion, as shown by arrows "B" in FIG. 10, of blades 180
and 190 of handle 170.
Aneurysm clip 50 of the present invention is applied by the neurosurgeon
using the aneurysm clip system (including cantilever spring 60, rigid ring
100, and applicator 120) of the present invention in the following manner.
FIG. 11 shows the two legs 140 and 160 of applicator 120 positioned
alongside open cantilever spring 60 and rigid ring 100 of aneurysm clip
50. Pin 142 on first leg 140 of applicator 120 is positioned in bend 80 of
cantilever spring 60. Projections 162 and 164 on the end of second leg 160
engage rigid ring 100. Specifically, one projection 162 engages one face
of rigid ring 100 while the other projection 164 engages the opposite face
of rigid ring 100 with the body of rigid ring 100 occupying space 166
between perpendicular projections 162 and 164. Applicator 120 may be
disposed inside a guide tube 200 to facilitate placement of applicator 120
(and cantilever spring 60 and rigid ring 100 held by applicator 120) at
the site of the cerebral aneurysm.
A scissoring or squeezing movement of blades 180 and 190 of handle 170
slides second leg 160 with respect to first leg 140. Pin 142 and first leg
140 keep cantilever spring 60 in a stationary position while projections
162 and 164 at the end of second leg 160 slide rigid ring 100 away from
bend 80, over arms 70 and 90, into engagement with third bulges 79 and 99,
and between the edges of first bulges 77, 97 and second bulges 78, 98 to
close cantilever spring 60 as shown in FIG. 12. An opposite movement of
blades 180 and 190 reverses the movement of rigid ring 100 and moves rigid
ring 100 toward bend 80 and off arms 70 and 90 to open cantilever spring
60. FIG. 9 shows a typical "upward" shaft applicator 120. It should be
noted that a "downward" shaft applicator would provide the reverse
relative motion of second leg 160 with respect to first leg 140.
Thus, legs 140 and 160 of applicator 120 are in close sliding contact and
move in response to scissoring or compression of handle 170. This sliding
motion pushes rigid ring 100 in either direction, for opening or closing
of arms 70 and 90. Pin 142 and projections 162 and 164 "hook" cantilever
spring 60 and rigid ring 100. This "hook" creates an efficient method of
applying or removing rigid ring 100 to or from cantilever spring 60.
Applicator 120 also allows the user to manipulate aneurysm clip 50.
Although illustrated and described herein with reference to certain
specific embodiments, the present invention is nevertheless not intended
to be limited to the details shown. Rather, various modifications may be
made in the details within the scope and range of equivalents of the
claims and without departing from the spirit of the invention.
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